How to Negotiate a Clinical Trial Budget with a Sponsor

Develop a good rapport with your sponsor contact; the best way to start budget negotiations is by maintaining a good working relationship with those who will be deciding your funding.  Start the budget negotiation process early to avoid rushing through the entire process.

  1. Remember the sponsor's initial offer is calculated for the average study site - not all sites are created equal!
    • Think monetary needs of site, and experience of staff
    • In most cases, the initial offer is NOT final
    • Negotiating the budget is unlikely to affect selection as a site
  2. Conduct a thorough analysis to determine if the funding is worth the cost to perform the study
    • Read and understand the protocol
      • There is a cost for every study-related item!
    • Identify a payer for each budget item
  3. Don't forget your major budget categories
    • Start-up charges (should request to be non-refundable as they will be charged whether or not any subjects are recruited
      • IRB fees (initial, amendments, and renewals)
      • OnCore/CRSC fees
      • DMC fees
    • Study preparation costs
      • PI's time
        • Protocol review
        • SIV
        • Investigator meeting
      • Coordinator's time
        • IRB application
        • Chart and/or database review
        • SIV
        • Protocol-specific training
      • Don't forget to include salary and fringe benefits!
    • Ancillary departments
      • Pharmacy fees
        • Study setup, maintenance, and close out
      • Lab fees
    • Additional costs
      • Contingent charges (invoiced only if they occur)
      • Serious Adverse Events
      • Screen failures
      • Unplanned visits
      • Advertising
    • Close-out charges
      • Study close-out visit
      • Pharmacy close-out
      • Administrative close-out
      • IRB close-out
      • Archiving
    • Charge for administrative costs when able - it costs personnel time to complete direct administrative responsibilities such as:
      • Budget development and negotiation
      • Compiling regulatory documentation
      • Preparing IRB application
      • ICF negotiation
      • Reviewing study subject bills